Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

NCT ID: NCT04452539

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-02

Study Completion Date

2020-11-30

Brief Summary

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Recent studies show an important influence of gender on inflammatory reactions. Cardiac surgery is associated with a major systemic inflammatory response. The investigators want to evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.

Detailed Description

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Gender plays an important role in the inflammatory response. This is due to hormonal influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass, is associated with a major inflammatory response. This response is even more marked in pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on mortality and major morbidity in paediatric patients undergoing cardiac surgery. The investigators will do a retrospective cohort study, analysing the local database of all paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any difference in mortality and /or major morbidity according to gender.

Statistical analysis:

The investigators will use a propensity score on 11 pre-operative variables clinically judged relevant. Both group will be matched until a absolute standardised difference \< 15% is obtained. This type of matching, contrary to a P value, is independent of sample size. Variables will be presented as mean, standard deviation or percentage for frequency distributions. After propensity score matching, logistic regressions will be performed on binary variables and linear regressions on continuous variables. A Bonferroni correction will be used for multiple comparisons.

Conditions

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Pediatric Cardiac Surgery Gender

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Paediatric cardiac surgery patients

All patients undergoing paediatric cardiac surgery

Paediatric cardiac surgery

Intervention Type PROCEDURE

All patients undergoing paediatric cardiac surgery

Interventions

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Paediatric cardiac surgery

All patients undergoing paediatric cardiac surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

* Jehova's witness
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Denis SCHMARTZ

Head, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denis Schmartz, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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Hôpital Universitaire des Enfants Reine Fabiola

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CHUB_GENDERPED

Identifier Type: -

Identifier Source: org_study_id

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